GxP Lifeline

The Quality Leader's Guide to Quality 4.0

As a new calendar year approaches, the technology at our disposal is exceeded only by the number of ways it can be applied to improve communication, understanding, planning and productivity. In fact, the last decade has seen such rapid advances in areas like connectivity, mobility, analytics, scalability and data that it has sparked a fourth industrial revolution, known as Industry 4.0. IT and operations teams are chomping at the bit to implement these new technologies to help them operate better, smarter and faster. But what does this mean for quality and the teams responsible for it?

FDA Draft Guidance on Electronic Records and Signatures: The Next Chapter

Just about everyone in the drug development industry has cited 21 CFR Part 11 at one time or another. Fondly referred to as “Part 11,” the August 1997 regulation was last referenced by the FDA in 2003 with the release of a Guidance for Industry - Part 11, Electronic Records; Electronic Signatures — Scope and Application.1 Since then, the centralized research team has significantly changed from only a few stakeholders into a system of many globally distributed contributors. The industry’s documentation has transitioned from paper files to dynamic, integrated systems supporting digital records spanning the bedside to the research clinic. The delivery of healthcare has evolved from the confines of brick and mortar to cloud-based platforms that could only be dreamed of a few years ago.

The Practical Guide to the ISO 13485:2016 Practical Guide

Manufacturers everywhere have been waiting a year and a half for additional guidance on the requirements of ISO 13485:2016, hoping September’s release of the "ISO 13485:2016 – A Practical Guide" (hereafter known as the “Practical Guide” or “Guide”) would bring the “practical” guidance promised.

Infographic: 10 Common Pains in Dossier Management for Med Device Firms

People say a picture is worth a thousand words. The 10 common pains in dossier management described in this infographic is worth ten thousand words given how much they affect the daily work of regulatory professionals and submission managers.

FDA Finalizes Guidance on When to Submit a 510(k) for a Change to an Existing Device

On October 25, 2017, FDA issued a final guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device. This guidance is a final version of the draft issued in 2016 (see our post on the 2016 draft here). Despite receiving a significant number of comments, the final guidance is largely unchanged from the 2016 draft. Industry should also be comforted to know that the final guidance is also, at its core, very similar to the 1997 guidance – a welcome relief as compared to the 2011 draft guidance.

Quality 4.0: Harnessing Technology to Enhance Traditional Quality Methods

Industries and manufacturers are increasingly approaching the challenge of digital transformation, some with caution, some with great anticipation, yet perhaps still others with unease. However, the message in a recent analyst report “Quality 4.0: Get Educated Get Involved, and Build a Successful Strategy” is clear—transform your company’s operations and efforts digitally or risk digital disruption. Forty percent of companies have already started a digital transformation initiative while another 17 percent kicked off initiatives in 2017, according to the report, which was co-sponsored by LNS Research and MasterControl.

Mobile Medical Apps & FDA Rules: What Is the Latest in 2017?

In the world of mobile apps, things change quickly, and it stands to reason that, as mobile phone makers added better processors, cameras, gyroscopes, and accelerometers, software developers followed with new apps that took advantage of the upgrades, perhaps offering apps that the hardware makers hadn’t even considered. Some of those apps did things that were medical in nature, and many of us in the medical device industry asked, “does the FDA regulate that?” The answer, of course, has been changing, and I’ll provide some background plus the latest on the rules, at least as of the date of this article.

Supplier Qualification: An Important - and Often Neglected - Validation Component

5 Guidelines for Writing a Useful Clinical Monitoring Report

A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight during an FDA inspection. Here are a few important guidelines you and your staff should follow to ensure your clinical monitoring reports are accurate and complete.

What Is Pharmaceutical Quality by Design?

It seems that Quality by Test is well on its way to being a thing of the past, and for good reason. With only one out of every 10 drug products actually making it to market, it is no surprise that pharma companies are increasingly eager to adopt measures to ensure quality and manage risk. Quality by Design (QbD) continues to be a hot topic across the life science industries, and as evidenced by the widespread adoption of QbD among manufacturers, there is no question about its benefits.

Don’t Let These Product Registration Problems Delay Your Time to Market

The combination of a lengthy process and high cost of drug development is a hard pill to swallow for pharmaceutical companies. It should serve as the biggest motivation for them to find fundamental ways to accelerate their overall time to market.

HIPAA Compliance and Data Security Demand Equal Attention

The Health Insurance Portability and Accountability Act (HIPAA) established by the U.S. Department of Health and Human Services (HHS) has been around since 1996. The components of HIPAA cast a wide net over regulations involving insurance coverage, medical records and tax rules. However, rapidly advancing technology and security threats are pointing a spotlight on the Privacy and Security rules that apply to electronic protected health information (ePHI).

Risk Mitigation in Clinical Research: It Starts with Study Startup

For clinical research, Study Startup (SSU) is the pivotal period that lays the groundwork for a successful study. By ensuring that the right sites are selected and target subjects are recruited in a timely and cost-effective manner, mission critical risks can be avoided that lead to runaway costs and delays.

QA vs. QC, Quality Control vs. Quality Management: What’s the Difference?

In a company organized properly, quality assurance resides independent of manufacturing and operations, and quality control resides within manufacturing and operations. But what is the difference?

How to Become a QP in Europe

Both the European Compliance Academy (ECA) and the European Qualified Person association (EQPA) are often contacted by people who would like to become a Qualified Person (QP according the EU Directives) outside of the EU. Is this possible?

Future Trends and Opportunities in Quality Assurance

It’s impossible to know exactly what future trends will influence the direction and methodologies of quality assurance (QA). However, according to Bristol Myers Squibb executive Donna Gulbrinski, looking at how quality professionals overcome current challenges can lend some insight on future QA strategies and processes.

Revisiting CAPA for a More Modern (and Effective) Approach

Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?

Gottlieb Says FDA Wants to Widen Access to Better Compounded Drugs

We have witnessed this past week some noteworthy activity in the drug compounding space. Where will this lead traditional compounders and outsourcing facilities? What will it mean for compounders in the months ahead? We will just have to wait until FDA releases anticipated draft guidance on changes in outsourcing facility compounding in the coming months. FDA’s announcement about draft outsourcing guidance is somewhat of a headscratcher, especially considering that a number of anticipated compounding guidance documents and regulations were recently moved to CDER’s regulatory agenda inactive list (here; search "drug").

FY2018 Increasing User Fees Affects Submission Strategy

Just in the nick of time at the end of August, Congress reauthorized the Medical Device User Fees (MDUFA) ensuring that FDA received vital funding to properly staff submission reviews and other activities. While the user fees for all submissions increased, de novo submissions saw the most significant increase. Historically, de novo submissions did not have a user fee. However, with FDA’s expansion of the de novo submission options to include direct de novo rather than conversion from a non-substantially equivalent 510(k) determination, the FDA was understaffed to accommodate the additional review burden. As a result, de novo submission review times could drag out 10 to 12 months.

Three Ways to Accelerate Your Lean Journey

I spent two days in St. Louis last week at the Global Lean Leadership Conference. It’s a small conference—only about 150 people—consisting of companies that have embraced Paul Akers’s 2 Second Lean philosophy. Companies that wanted to join the conference were required to have the president attend (although there were many other people from those companies as well).